A Study to Explore the Efficacy of Alprostadil Liposomes Injection in the Prevention of CI-AKI

NCT ID: NCT05475717

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2024-01-03

Brief Summary

This is a multicenter, randomized, open-label phase II clinical trial to evaluate alprostadil liposomal injection in the prevention of contrast-induced acute kidney injury in patients undergoing percutaneous coronary intervention.

Detailed Description

The trial is a multicenter, randomized, open-label, two-stage study. The trial period includes a screening period (up to 14 days), a treatment period (4 days), and a safety follow-up period (7 days ± 3 days). At least 368 patients with pre-PCI (percutaneous coronary intervention) are expected to be included, and all patients will be contrasted with non-ionic hypotonic/isotonic contrast media.

The trail will be divided into two stages. Three dose groups are set in the first stage: 20 µg/day, 40 µg/day and 80 µg/day. In the first stage, on the basis of hydration prevention, patients will randomized to receive 20, 40 or 80 µg/day of alprostadil liposome injection for 4 days (1 to 3 hours before surgery and 3 days after surgery), once a day. The blank control group will only receive hydration prophylaxis. In the second stage, according to the comprehensive evaluation of the data in the first stage, a dose group will be selected to continue to be enrolled. The primary outcome measure is the incidence of contrast-induced acute kidney injury within 72 hours after PCI. During the administration of alprostadil liposomal injection, vital signs, physical examination, ECOG performance status, laboratory test, ECG, adverse events and PK parameters will be evaluated.

Conditions

Contrast-induced Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

20 µg group

Patients will receive alprostadil liposome injection at 20 µg once daily (QD) for 4 days (1 to 3 hours before surgery and 3 days after surgery).

Group Type: EXPERIMENTAL

Alprostadil liposome injection

Intervention Type: DRUG

Alprostadil liposome injection, iv drip, QD×4 days (1 to 3 hours before surgery and 3 days after surgery)

40 µg group

Patients will receive alprostadil liposome injection at 40 µg once daily (QD) for 4 days (1 to 3 hours before surgery and 3 days after surgery)

Group Type: EXPERIMENTAL

Alprostadil liposome injection

Intervention Type: DRUG

Alprostadil liposome injection, iv drip, QD×4 days (1 to 3 hours before surgery and 3 days after surgery)

80 µg group

Patients will receive alprostadil liposome injection at 80 µg once daily (QD) for 4 days (1 to 3 hours before surgery and 3 days after surgery)

Group Type: EXPERIMENTAL

Alprostadil liposome injection

Intervention Type: DRUG

Alprostadil liposome injection, iv drip, QD×4 days (1 to 3 hours before surgery and 3 days after surgery)

blank control group

Patients will receive only basic hydration therapy which the experimental groups will receive.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Alprostadil liposome injection

Alprostadil liposome injection, iv drip, QD×4 days (1 to 3 hours before surgery and 3 days after surgery)

Intervention Type: DRUG

Other Intervention Names

Alprostadil liposome

Eligibility Criteria

Inclusion Criteria

1. Agree to participate in this clinical trial and sign the informed consent voluntarily; 2.18≤age≤80 years old, gender is not limited; 3.Suffering from coronary artery disease and preparing to undergo elective PCI; 4.Serum creatinine>1.5 mg/dL or 30≤eGFR<60 mL/(min·1.73m^2), and meet at least one of the following risk factors:

1. Cardiac function class NYHA class III;

2. Age > 75 years old;

3. Anemia (baseline hematocrit: <36% in women, <39% in men);

4. Diabetes.

Exclusion Criteria

1. Pre-perform emergency PCI;

2. Previously allergic to alprostadil similar products and contrast agents; used alprostadil within 3 days before the first administration;

3. Severe renal insufficiency: renal replacement therapy may be performed in a short period of time or eGFR<30 mL/(min·1.73m^2);

4. Severe heart failure (LVEF <35% or NYHA class IV), acute heart failure, and pulmonary edema;

5. Requires mechanical circulatory support therapy (intra-aortic balloon pump, catheter-based ventricular assist device, venous-arterial extracorporeal membrane oxygenation therapy, etc.);

6. Hypotension: systolic blood pressure < 90 mmHg;

7. Acute bleeding disorders or bleeding tendency, and the investigators believe that they are not suitable to participate in this trial;

8. Severe anemia (hemoglobin <60 g/L);

9. Active hepatitis B virus infection (positive hepatitis B virus surface antigen and the quantitative detection value of hepatitis B virus DNA exceeds the upper limit of the normal range of the research center), positive for any one of hepatitis C virus antibody, HIV antibody, and Treponema pallidum antibody;

10. Abnormal liver function (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times the upper limit of normal);

11. Contrast agents or known nephrotoxic drugs (aminoglycoside antibiotics, amphotericin B, vancomycin, antiviral drugs, non-steroidal anti-inflammatory drugs (except aspirin), Immunosuppressants, traditional Chinese medicines and proprietary Chinese medicines containing aristolochic acid, etc.) within 14 days before the first application of the test drug, or the use of drugs that protect the kidneys against AKI (N-acetylcysteine, sodium bicarbonate, aminophylline) within 3 days before the first application of the test drug;

12. Severe renal artery stenosis, and in the opinion of the the investigator, is unsuitable to participate in this trial;

13. Electrolyte disorders (serum potassium <2.5 mmol/L or serum sodium <125 mmol/L);

14. A history of glaucoma or ocular hypertension or gastric ulcer;

15. Interstitial pneumonia or mental illness or dementia;

16. Malignant tumors;

17. Have participated in drug clinical trials and used drugs within 3 months before screening;

18. Pregnant or breastfeeding, or patients who cannot use effective contraception during the study;

19. Other patients deemed unsuitable for participation in this trial by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wen Xu, Derector

Role: STUDY_DIRECTOR

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Locations

Beijing University First Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

HF1307-004

Identifier Type: -

Identifier Source: org_study_id